Sanofi Made False Claims About RSV Shot for Infants, FDA Says

In a letter to the drugmaker, the FDA said the agency approved Beyfortus, an RSV monoclonal antibody, as a defense against RSV lower respiratory tract disease — but that Sanofi has been claiming it protects broadly against RSV disease, which occurs in the lower and upper tracts. Beyfortus has come under scrutiny following reports of at least two infant deaths during clinical trials for the drug. The U.S. Food and Drug Administration (FDA) is accusing Sanofi of making false or misleading promotional claims about Beyfortus, a preventative treatment for RSV, Fierce Pharma reported. In a letter to the drugmaker, the FDA said it approved Beyfortus specifically as a defense against respiratory syncytial virus (RSV) lower...

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